It is well documented in clinical studies that approximately 50% of the ambulatory patients in the United States have difficulty remembering how and when to take their medications or comply with various treatment regimens (for example, fasting, exercise and dietary constraints). Complex treatment regimens, chronic diseases, physical or mental impairments, discipline problems, lack of pain, busy schedules, and age all contribute to noncompliance with prescribed therapies in homes and offices. In group settings, such as long-term care facilities, hospitals and nursing homes, additional compliance problems are caused by dosage errors, accurate and timely distribution of medications, and adherence to the particular regimen instructions. These occur because shortages of qualified nurses or caregivers are faced with an ever larger group of patients and an increasing count of corresponding medications and treatment regimens. Further, with the aging of the baby boom and the shortage of caregivers, it is anticipated that efforts to monitor the compliance of patients with treatment regimens will become ever more problematic.
Additionally, it is commonly known and appreciated that many prescription drugs or health aids, such as vitamins and health supplements, have specific ingestion requirements to ensure their effectiveness or minimize unnecessary side effects. These include, but are not limited to, taking the medication before or after a meal, with or without liquids, not in conjunction with certain drugs or alcohol usage, if pregnant, before or after menopause, and whether dependent upon a status of injury or presence of a chronic disease. The need to communicate accurate instructions for each specific medication becomes even more important when the patient is required to take more than one medication, vitamin, supplement, meal, or treatment regimen multiple times each day with a varying schedule and changes in dosage, frequency, and other variables.
Also, patients are often provided instructions for treatment regimens by various medical professionals and caregivers. Such professionals and caregivers include, but are not limited to, doctors, nurses, medical technicians, physical therapists, and dieticians. Throughout this disclosure (for purposes of simplicity) such professionals and caregivers are commonly referred to as “Doctors”. Those skilled in the art appreciate the various legal and regulatory limitations placed upon individual caregivers, and the use of the term “Doctors” is not to be construed as limiting the present invention to persons holding advanced degrees in medicine or any other level of certification or licensing. Similarly, those responsible for dispensing or providing controlled medications commonly are pharmacists. However, doctors and nurse practitioners often provide samples to patients which are not dispensed through a pharmacy. For purposes of simplicity, a person dispensing a medication to a patient which the patient may administer to themselves or have administered to them (for example, with the aid of a nurse or other assistant) shall herein be collectively referred to as a “Pharmacist”.
Currently, two standard methods are often used by Doctors to instruct patients on treatment regimens and specifically on how to take medications properly. One of these methods utilizes written and/or verbal instructions which pertain to a specific treatment regimen and are communicated by the Doctor directly or indirectly to the patient. Such instructions are often communicated in person, at a Doctor's office, however, remote instructions (including those via telephone, video links, facsimile, e-mail and other communications links) are also utilized. As is well known in the art, patients often misconstrue the instructions communicated by a Doctor because the patient is in pain during the visit, gets confused by the technical explanations, have comprehension difficulties, can not remember the precise instructions, are unable to read the Doctor's handwriting, and/or for various other reasons. Further, many medication and treatment regimens are time and/or sequence specific and/or require non-medication treatment regimens to be performed in order for the medication to be effective. In such circumstances, medication and/or treatment regimens may not be readily available to the patient at the preferred treatment time(s). Additionally, those assisting a patient in taking medications (for example, a son or daughter of an elderly person) are often not present when the Doctor communicates the treatment instructions and thus may not be fully informed of the recommended treatment regimen.
Further complicating the prescribing, administering and monitoring of treatment regimens for a patient is the fact that Doctors and Pharmacists often utilize inefficient and ineffective communication methods. Many persons are familiar with the practically illegible scripts Doctors commonly utilize to prescribe medications. In fact, it is commonly appreciated that there is a need for effective communication links between Doctors, patients, attendees, Pharmacists and others associated with treating patients.
Further, provided that proper consent and authorization has been provided, Doctors, Pharmacists and others often need to safely and securely share pertinent and secure information about a patient. Doctors, Pharmacists and others often need to also exchange current medical research data on diseases, impairments, medications or therapies and other information. Under current practices, Doctors and Pharmacists often must rely on the patient to furnish accurate and complete information regarding their medications, health supplements, and compliance history. Patients have to often provide this information (often collected in the form of a checklist followed by oral questions) because the means for a common electronic transfer system are not in place. The reasons often cited for this lack of a common electronic transfer systems include the lack of a unified software platform, equipment compatibility, and costly subscriptions fees. Consequently, Doctors and Pharmacists often are not fully appraised of a patient's condition. Referred Doctors (e.g., an orthopedic specialist), who may not be approved by the patient's insurance carrier or practices outside a specified health maintenance or preferred provider organization, often will not receive a complete patient profile which is needed to make an informed diagnosis and prescribe an effective and safe (when possible) treatment regimen.
A similar need exists to link medical professionals with current research information on diseases, impairments, medications or therapies from independent companies at an affordable cost. Many Doctors and Pharmacists rely on medical journals, independent research, paid subscriptions and promotional materials supplied by manufacturer representatives to stay current with the ever-changing medical field. This is a timely and expensive process that can become overwhelming given the increasing patient load commonly being seen and cared for by today's Doctors.
Further, the number of medications taken by a patient can vary from none to several dozen or more depending on age, the type or stage of a particular disease, physical or mental impairments, and the occurrence of a new injury or accident. Each medication typically has its own specific regimen (which should be followed to avoid unnecessary complications and/or undesired side effects) and comes in a variety of sizes, shapes and unit counts. Consequently, the need exists for a base-operating platform that can be used, in one or more devices sized to accommodate the different dispensing needs, to assist in the administration of a given treatment regimen. Some individual patients may require a small, portable device or a table-top version for home use, whereas a long-term care facility may require a larger unit or a surface-mounted station to handle the needs of many patients.
It is also commonly appreciated in the medical community that medications can be extremely dangerous if taken improperly. Thus, a need exists for a device that is easy to use, is capable of providing instructions for the treatment regimen, and contains a series of redundant safety features that enables a patient, caregiver or third-party individual to administer the taking of the medication in pre-selected doses at pre-determined times without having to receive separate instructions from a Doctor or Pharmacist. From the medical professional's perspective, the interfacing software used to program the device is preferably easy to use and facilitates the efficient entry of data and instructions and the retrieval of compliance information. Further, such a device is desirably capable of being interactively programmed from a remote source.
Therefore, there is a need for a system and process which enables a Doctor to communicate patient information with other Doctors and/or Pharmacists. Such a system also desirably enables the attending Doctor to efficiently determine whether a treatment regimen may be contra-indicated for a specific patient based upon patient information, general medical information, medication interaction information, and other information. The system also desirably enables a Doctor or Pharmacist to monitor the patient's compliance with the prescribed treatment regimen.
As mentioned previously, two methods are often used to communicate a treatment regimen to a patient. A second method often utilizes prescription labels attached to a pill-box or medication container (a “Container”) by a Pharmacist. Due to the limited space on a Container, these instructions are typically very brief or abbreviated. More complete instructions, including warnings, side effects and instructions for taking the medication, may be provided in the retail or wholesale packaging but are often printed in a very small font and discarded after the package is opened. Since patients often require the assistance of others to take their medications, the Container and associated packaging materials are often ineffective in properly and routinely notifying a patient or their caregiver about a treatment regimen. Further, such Containers commonly do not provide a reliable mechanism for monitoring compliance by the patient with a treatment regimen.
Currently, there are several electronic alarm devices available which are designed to help patients determine when medications should be taken. While such devices are generally effective at providing audible notification signals, such devices do not provide the before mentioned and desired features and functions and generally have many shortcomings. For example, such devices usually do not properly address the problem of instructing a patient on how to take their medications. Nor do such devices enable Doctors and/or Pharmacists to program the device with customized instructions and related warnings which are automatically converted into verbalized speech (when necessary) for communication to the client. As such, commonly available devices hinder the accommodation of changing medications and treatment regimens. These devices also do not provide a system and process which verifies whether a treatment regimen (which may include activities such as diet and exercise in addition to medications) is appropriate for a patient and do not monitor the compliance by the patient with such a regimen.
Another problem with current devices is the fact that third-party assistance is often necessary to open a prescription container or organize a patient's medications for a particular day, week or month, especially if a physical or mental impairment exists. This process can be costly, inaccurate and time-consuming depending on the competency of the patient's caregiver. Presently, Pharmacists do not directly fill medication organizers (i.e., containers for storing multiple medications taken by a patient on a regular basis) and, by law, are required to use only pre-approved containers with childproof caps, unless granted permission by the primary care physician for an easy-open cap. In nursing homes, long-term care facilities, and similar locations, only a registered nurse is allowed to sort the medications for dispensing to the patients.
Existing childproof caps for prescription, non-prescription and health supplement containers commonly function by either a press-turn motion or a press-squeeze-turn motion. These caps can be extremely difficult to open for the elderly and those with arthritis and coordination impairments. In moments of crisis, the problem is compounded by the tension and anxiety experienced by the patient. In addition, none of the caps supplied by the Pharmacist can monitor the opening or closing of the container to determine if the patient is in compliance with the prescribed treatment regimen. Therefore, a device is needed which allows patients to access medications with preferably little if any assistance while also allowing Doctors and/or Pharmacists to monitor compliance by the patient with a treatment regimen.